{"id":9192,"date":"2026-10-09T21:45:14","date_gmt":"2026-10-09T20:45:14","guid":{"rendered":"https:\/\/wheat-quail-856400.hostingersite.com\/?p=9192"},"modified":"2026-11-12T18:49:57","modified_gmt":"2026-11-12T17:49:57","slug":"serum-free-media-for-atmp-manufacturing-cho-and-hek293-side-by-side","status":"publish","type":"post","link":"https:\/\/seamlessbio.de\/de\/serum-free-media-for-atmp-manufacturing-cho-and-hek293-side-by-side\/","title":{"rendered":"Serumfreie Medien f\u00fcr die ATMP-Herstellung: CHO und HEK293 im Vergleich"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"9192\" class=\"elementor elementor-9192\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-76c4ae0c e-flex e-con-boxed e-con e-parent\" data-id=\"76c4ae0c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-71daa090 elementor-widget elementor-widget-text-editor\" data-id=\"71daa090\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n<p class=\"wp-block-paragraph\">Serumfreie Medien f\u00fcr die ATMP-Herstellung: CHO und HEK293 im Vergleich | SeamlessBio<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Arzneimittel f\u00fcr neuartige Therapien \u2013 Gentherapien, Zelltherapien, biotechnologisch bearbeitete Gewebeprodukte \u2013 sind auf robuste, GMP-konforme und skalierbare Upstream-Zellkulturprozesse angewiesen. Im Zentrum der meisten ATMP-Upstream-Prozesse steht eine von zwei Produktionsplattformen: CHO-Zellen f\u00fcr therapeutische Proteine und virale Vektoren zur Ex-vivo-Modifikation oder HEK293-Zellen f\u00fcr die Herstellung viraler Vektoren.<\/p>\n<!-- BUY BOX (SEO: links to buy pages) -->\n<div class=\"sb-buy-box\" style=\"border:1px solid #cfe9e6;background:#f4fbfa;border-radius:12px;padding:22px 26px;margin:28px auto;max-width:1200px;box-sizing:border-box\">\n<h2 style=\"font-size:22px;line-height:1.3;margin:0 0 6px\">Serumfreie Zellkulturmedien ab EU-Lager kaufen<\/h2>\n<p style=\"margin:0 0 14px\">Angebot oder Testmuster anfragen \u2013 keine Mindestbestellmenge, Angebot innerhalb von 48 Stunden.<\/p>\n<ul style=\"margin:0;padding-left:20px;columns:2 300px;column-gap:32px\">\n<li style=\"margin:0 0 6px\"><a href=\"https:\/\/seamlessbio.de\/de\/produkt\/simplacex-serumfreies-medium-hek293t\/\">SimplaceX \u2013 serumfreies HEK293T-Medium<\/a><\/li>\n<li style=\"margin:0 0 6px\"><a href=\"https:\/\/seamlessbio.de\/de\/produkt\/simplacecdx-chemisch-definiertes-medium-hek293t\/\">SimplaceCDX \u2013 chemisch definiertes HEK293T-Medium<\/a><\/li>\n<li style=\"margin:0 0 6px\"><a href=\"https:\/\/seamlessbio.de\/de\/produkt\/naivacore-naives-ipsc-medium-hensm\/\">NaivaCore \u2013 naives iPSC-Medium (HENSM)<\/a><\/li>\n<li style=\"margin:0 0 6px\"><a href=\"https:\/\/seamlessbio.de\/de\/serumfreies-medium-cho\/\">Serumfreie CHO-Zellkulturmedien<\/a><\/li>\n<li style=\"margin:0 0 6px\"><a href=\"https:\/\/seamlessbio.de\/de\/produkt\/cellimax-metacho-cd-cho-basalmedium\/\">CelliMax\u00ae MetaCHO &amp; Versa \u2013 CHO-Basalmedien<\/a><\/li>\n<li style=\"margin:0 0 6px\"><a href=\"https:\/\/seamlessbio.de\/de\/produkt\/cellimax-cho-fga-feedmedium\/\">CelliMax\u00ae CHO-Feeds \u2013 FGa, FGa plus, FGb<\/a><\/li>\n<li style=\"margin:0 0 6px\"><a href=\"https:\/\/seamlessbio.de\/de\/serumfreies-msc-medium-gmp\/\">Serumfreies MSC-Medium<\/a><\/li>\n<li style=\"margin:0 0 6px\"><a href=\"https:\/\/seamlessbio.de\/de\/serumfreies-ipsc-medium-gmp\/\">Serumfreies iPSC- &amp; hESC-Medium<\/a><\/li>\n<li style=\"margin:0 0 6px\"><a href=\"https:\/\/seamlessbio.de\/de\/anwendungen\/organoid-3d-cell-culture\/\">OrganoMedium \u2013 Medium f\u00fcr die Organoid-Expansion<\/a><\/li>\n<li style=\"margin:0 0 6px\"><a href=\"https:\/\/seamlessbio.de\/de\/massgeschneiderte-zellkulturmedien\/\">Ma\u00dfgeschneiderte Zellkulturmedien \u2013 individuelle Formulierung<\/a><\/li>\n<\/ul>\n<p style=\"margin:14px 0 0\"><a href=\"https:\/\/seamlessbio.de\/de\/request-quote\/\" style=\"font-weight:600\">Angebot anfordern \u2192<\/a><\/p>\n<\/div>\n<!-- \/BUY BOX -->\n\n\n\n\n<p class=\"wp-block-paragraph\">Serumfreies Medium ist in beiden F\u00e4llen keine Option, sondern regulatorische Erwartung und fertigungstechnische Notwendigkeit.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warum die ATMP-Herstellung serumfreie Medien erfordert<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Die ATMP-Klassifizierung der EMA und die EU-ATMP-Verordnung (1394\/2007) stellen hohe Anforderungen an die Charakterisierung von Rohstoffen. Materialien tierischen Ursprungs \u2013 allen voran FKS \u2013 bringen mit sich:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>TSE\/BSE-Risiko<\/strong>: erfordert TSE-Zertifikate des EDQM und eine Begr\u00fcndung der Herkunft nach Ph. Eur. 5.2.8<\/li>\n\n\n\n<li><strong>Chargenvariabilit\u00e4t<\/strong>: Jede FKS-Charge ist biologisch verschieden; GMP-Prozesse vertragen keine undefinierte Variabilit\u00e4t bei kritischen Rohstoffen<\/li>\n\n\n\n<li><strong>Risiko einer Verunreinigung des Endprodukts<\/strong>: R\u00fcckst\u00e4nde boviner Proteine k\u00f6nnen im Endprodukt auftauchen und erfordern einen Nachweis der Abreicherung<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Serumfreie, chemisch definierte Medien l\u00f6sen alle drei Punkte: vollst\u00e4ndige Charakterisierung der Komponenten, keine Rohstoffe tierischen Ursprungs, gleichbleibende Leistung von Charge zu Charge.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">CHO-Zellen in der ATMP-Herstellung<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">CHO-Zellen kommen in zwei ATMP-nahen Zusammenh\u00e4ngen vor.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. Herstellung therapeutischer Proteine f\u00fcr Ex-vivo-Zelltherapien.<\/strong> Zytokine, Wachstumsfaktoren und rekombinante Proteine zur Expansion oder Vorbehandlung von Zelltherapieprodukten (T-Zellen, NK-Zellen, MSCs) werden h\u00e4ufig in CHO produziert. Diese Proteine m\u00fcssen unter GMP mit vollst\u00e4ndiger Charakterisierung hergestellt werden \u2013 serumfreies, chemisch definiertes Medium ist hier Standard.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. Herstellung viraler Vektoren.<\/strong> Einige AAV-Herstellungsplattformen nutzen CHO oder davon abgeleitete Zelllinien. H\u00e4ufiger findet sich CHO in Strategien mit stabilen Produzentenzelllinien f\u00fcr die gro\u00dftechnische Herstellung retroviraler oder lentiviraler Vektoren \u2013 ein Feld in aktiver Entwicklung.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">F\u00fcr CHO-basierte ATMP-Upstream-Prozesse gelten folgende Anforderungen an das Medium: chemisch definiert, vorzugsweise proteinfrei, Dokumentation der Freiheit von tierischen Bestandteilen, ISO-13485- oder GMP-Zertifizierung des Lieferanten.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u2192 <a href=\"\/de\/serumfreies-medium-cho\/\">Serumfreie Medien f\u00fcr CHO-Zellen bei SeamlessBio<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">HEK293-Zellen in der ATMP-Herstellung<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">HEK293 ist die dominierende Produktionsplattform f\u00fcr virale Vektoren in der ATMP-Herstellung:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>AAV-Vektoren<\/strong> f\u00fcr die In-vivo-Gentherapie (Netzhautdystrophien, H\u00e4mophilie, neuromuskul\u00e4re Erkrankungen)<\/li>\n\n\n\n<li><strong>Lentivirale Vektoren<\/strong> f\u00fcr die Ex-vivo-Modifikation von CAR-T- und TCR-T-Zellen<\/li>\n\n\n\n<li><strong>Adenovirale Vektoren<\/strong> f\u00fcr bestimmte Impfstoff- und Genkorrekturplattformen<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">In allen F\u00e4llen erwarten die Beh\u00f6rden f\u00fcr die klinische GMP-Herstellung ein serumfreies, chemisch definiertes Medium mit vollst\u00e4ndiger R\u00fcckverfolgbarkeit. In Phase I\/II kann ein chemisch definiertes Medium in Forschungsqualit\u00e4t mit geeigneten Bridging-Studien akzeptabel sein. F\u00fcr Zulassungsstudien und die kommerzielle Herstellung ist ein Medium in GMP-Qualit\u00e4t mit ISO-13485-Dokumentation erforderlich.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u2192 <a href=\"\/de\/serumfreies-medium-hek293\/\">Serumfreie Medien f\u00fcr HEK293-Zellen bei SeamlessBio<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">CHO vs. HEK293 \u2013 direkter Vergleich<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><\/th><th>CHO<\/th><th>HEK293<\/th><\/tr><\/thead><tbody><tr><td>Hauptanwendung im ATMP-Bereich<\/td><td>Therapeutische Proteine, einige virale Vektoren<\/td><td>AAV-, lentivirale und adenovirale Vektoren<\/td><\/tr><tr><td>Kulturformat<\/td><td>Suspension (Standard)<\/td><td>Adh\u00e4rent (HEK293T\/FT) oder Suspension (HEK293F)<\/td><\/tr><tr><td>Wichtigste Medieneigenschaft<\/td><td>Chemisch definiert, proteinfrei<\/td><td>Albuminarm, f\u00fcr Transfektion optimiert<\/td><\/tr><tr><td>GMP-Anforderung<\/td><td>ISO 13485, vollst\u00e4ndiges CoA<\/td><td>ISO 13485, vollst\u00e4ndiges CoA<\/td><\/tr><tr><td>Regulatorische Einstufung<\/td><td>AOF bevorzugt<\/td><td>AOF bevorzugt<\/td><\/tr><tr><td>Weg zum Scale-up<\/td><td>R\u00fchrkesselbioreaktor<\/td><td>Bioreaktor (Suspension) oder Mehrlagenflasche (adh\u00e4rent)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Den richtigen Lieferanten w\u00e4hlen<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">In der ATMP-Herstellung ist die Wahl des Mediums eine kritische Qualit\u00e4tsentscheidung \u2013 keine Einkaufsentscheidung. Der Lieferant muss Folgendes bereitstellen:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Vollst\u00e4ndige Komponentenliste mit CAS-Nummern und Herkunftsdokumentation<\/li>\n\n\n\n<li>Erkl\u00e4rung zur Freiheit von tierischen Bestandteilen mit R\u00fcckverfolgbarkeit bis auf Rohstoffebene<\/li>\n\n\n\n<li>Herstellung in GMP-Qualit\u00e4t mit ISO-13485-Zertifizierung<\/li>\n\n\n\n<li>Chargenspezifisches CoA und CoO<\/li>\n\n\n\n<li>Regulatorische Unterlagen zur Unterst\u00fctzung von IND-\/IMPD-Einreichungen<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">SeamlessBio beschafft und liefert serumfreie, chemisch definierte Medien f\u00fcr CHO- und HEK293-Plattformen \u2013 mit Optionen in GMP-Qualit\u00e4t und vollst\u00e4ndiger regulatorischer Dokumentation f\u00fcr ATMP-Hersteller in der EU und im Vereinigten K\u00f6nigreich.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u2192 Sprechen Sie mit SeamlessBio \u00fcber die Medienanforderungen Ihres ATMP-Herstellungsprozesses.<\/strong><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Serum-Free Media for ATMP Manufacturing: CHO and HEK293 Side by Side | SeamlessBio Advanced therapy medicinal products \u2014 gene therapies, cell therapies, tissue-engineered products \u2014 depend on upstream cell culture processes that are robust, GMP-compliant and scalable. At the centre of most ATMP upstream processes is one of two production platforms: CHO cells for therapeutic [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","footnotes":""},"categories":[46,256],"tags":[],"class_list":["post-9192","post","type-post","status-publish","format-standard","hentry","category-cell-culture","category-serum-free"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Serum-Free Media for ATMP Manufacturing: CHO and HEK293<\/title>\n<meta name=\"description\" content=\"ATMP manufacturing depends on the right serum-free medium \u2014 whether you produce viral vectors in HEK293 or therapeutic proteins in CHO. 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